Clinical equipoise and the incoherence of research ethics

Franklin G. Miller, Howard Brody

Research output: Contribution to journalArticle

58 Citations (Scopus)

Abstract

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry.

Original languageEnglish (US)
Pages (from-to)151-165
Number of pages15
JournalJournal of Medicine and Philosophy
Volume32
Issue number2
DOIs
StatePublished - Mar 2007

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Research Ethics
research ethics
Randomized Controlled Trials
medical care
Clinical Ethics
obligation
Physicians
physician
Patient Care
Therapeutics
doctrine
appeal
moral philosophy
boldenone undecylenate
Incoherence
Randomized Controlled Trial
Medical Care
Obligation

Keywords

  • Clinical equipoise
  • Exploitation
  • Randomized controlled trials
  • Risk-benefit assessment

ASJC Scopus subject areas

  • Social Sciences (miscellaneous)
  • Public Health, Environmental and Occupational Health

Cite this

Clinical equipoise and the incoherence of research ethics. / Miller, Franklin G.; Brody, Howard.

In: Journal of Medicine and Philosophy, Vol. 32, No. 2, 03.2007, p. 151-165.

Research output: Contribution to journalArticle

Miller, Franklin G. ; Brody, Howard. / Clinical equipoise and the incoherence of research ethics. In: Journal of Medicine and Philosophy. 2007 ; Vol. 32, No. 2. pp. 151-165.
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